office of research integrity assurance

Office of Sponsored Programs

All rights reserved GTRC

Office of Research Integrity Assurance

Melanie ClarkResearch Admin Buzz meeting



Name ChangeOffice of Research Compliance is now Office of Research Integrity AssuranceNew URL– http://researchintegrity.gatech.edu/



IRB APPROVAL NEEDED



Conflict of Interest Management Office

Jeff SteltzerResearch Admin Buzz meeting



FCOI Applies toAny PHS research funding by means of a grant, cooperative agreement and though the implementation of Subpart F by the Institution.



PHS AgenciesAgency for Healthcare Research and Quality (AHRQ)Agency for Toxic Substances and Disease Registry (ATSDR)Centers for Disease Control and Prevention (CDC)Food and Drug Administration (FDA)Health Resources and Services Administration (HRSA)Indian Health Service (IHS) National Institutes of Health (NIH)Substance Abuse and Mental Health Services Administration (SAMHSA)



What awards and who?

As of August 24, 2012 all awards will require the PI have disclosed the FCOI.Applies to: – New awards– Competing Continuations – Noncompeting Continuations– Change of Institution

This doesn’t apply to NCEs.

2011 2012 2013August 24, 2012



FCOI and SubawardsFDP ClearinghouseLetter of Intent- include a certification that they are in compliance w/ regulationsNot in FDP Clearinghouse-– Institution must provide a URL or paper copy

of their COI policy



FCOI and SubawardsSubawards may NOT incur preaward costs. Costs cannot incurred until :– All disclosures have been made and any

possible conflicts have been eliminated, reduced, or managed.

– AND A fully executed agreement is in place.



New Routing SheetSPONSOR DATA

SPONSORING ORGANIZATION NAME (FUNDING ORGANIZATION OR THE ORGANIZATION THE SUBAWARD IS FROM) MAILING ADDRESS OF SPONSORING ORGANIZATION

SPONSOR’S TECHNICAL CONTACT

PHONE EMAIL

ADMINISTRATIVE CONTACT

PHONE EMAIL

NAME OF SPONSORING GOVERNMENT ORGANIZATION (ISSUING THE PRIME CONTRACT), IF APPLICABLE: PRIME CONTRACT NUMBER:

SOURCE OF FUNDS, IF DIFFERENT FROM SPONSORING ORGANIZATION OR PRIME: CONTRACT NUMBER FOR SOURCE OF FUNDS:

CHECK PREFERRED MAILING METHOD. ELECTRONIC _____ ____________________ (EMAIL OR FAX IF APPLICABLE) EXPRESS COURIER_____ U.S. EXPRESS MAIL_____ FIRST CLASS CERTIFIED ______

COURIER (HAND DELIVERY) ADDRESS

ACCOUNT TO BE CHARGED:

YES NO SPECIAL REVIEW CHECKLIST: THE PROPOSAL SUBMITTED INVOLVES THE FOLLOWING

Human Subject Research? IRB Protocol Number:__________________ Expiration Date: _____________ Vertebrate Animals? IACUC Protocol Number:__________________ Expiration Date: _____________ Recombinant DNA? IBC Registration Number ____ Expiration Date: _____________

Applicants may request a deferral to submit a funding proposal without an approved protocol as required by GT policy. Requests must be made in writing to your Contracting Officer who will obtain institutional approval for such action. NOTE: No awards will be accepted without an approved GT protocol in place.

Select Agents See list at www.cdc.gov/od/sap/docs/salist.pdf More info: www.cdc.gov/od/sap/ Biological agents: Check all that apply: Infectious or pathogenic agent(s) Human tissues or bodily fluid Other biological materials Physical Agents. Check all that apply: Chemicals Sharps Laser Radiation Thermal agent Materials Transfer Agreement (MTA) Professional Education Program (if yes, please route to DLPE) Subaward(s) are proposed Teaming Agreement Research involves export of info or materials to another country Research involves a foreign sponsor or collaborator, or will be performed in whole or in part outside the U.S. Contract anticipated to contain restrictions on publication or the use of Foreign Nationals Involves the use of pre-existing (background) intellectual property Georgia Tech’s Third Party’s –explain in comments section. A member of the research team has a Significant Financial Interest (SFI) related to this project. If “yes,” you must complete the Proposal Financial

Interest in Research Report within eCOI. https://ecoi.research.gatech.edu.


Proposal Preparation & Submission

CertificationsI certify that I have read and understand the Institute's conflict of interest policy all required financial disclosures were made; and I will comply with any conditions or restrictions imposed by the Institute to manage, reduce, or eliminate conflicts of interestcoi.research.gatech.edu



FCOIAll PHS proposals must use new routing sheet immediately. Everyone else Oct 2012.All Investigators must have AC completed prior to proposal submission.Any students involved in design, conduct, or reporting of research must be named and complete an AC.

80% of Invention Disclosures include students



More FCOI policies to come??American Heart AssociationAmerican Cancer SocietyBill & Melinda Gates FoundationNational Science Foundation

OIG review showed NSF was not sufficiently monitoring possible conflicts of interest



eCOI Systemhttps://ecoi.research.gatech.edu

https://ecoi.research.gatech.edu/



Grants and Contracts Accounting

Sandy MasonResearch Admin Buzz meeting



Cost Share Accounting and Reporting Expenses should be posted to separately-budgeted

companion cost share projects as incurred during the award performance period

Prior year documentation and/or certification require additional approvals

Quarterly report based on data in admin systems

Sponsored Project Exceptions

G&C Updates



ARRA Reporting – Quarter ending 9/30/12 PI Quarterly Update Deliverables

Timely submission by stated OSP deadlines – The reports must be filed by the Federal deadline

OMB Guidance – Acceleration of Unspent Funds Federal Agencies have been directed to take steps to

complete ARRA projects by September 30, 2013 Update from NSF – NSF has submitted a draft waiver

request to OMB and will reach out to each PI to let them know if their award (with a current term date after 9/30/13) was included in the request

G&C Updates



G&C UpdatesNIH Salary Cap Base Salary reduced to Executive Level II amount

($179,700) on new awards with initial Issue Date on/after Dec. 23,2011 Reference G&C Notice 12-I, dated January 24, 2012

(http://grants.gatech.edu/main/wp-content/uploads/2011/12/NIH_SalCap0112.pdf)

Requires additional Institutional funding Not part of required Cost Share Questions: Contact Robert Ellington, SPD Center

4-3488 or [email protected]




Candice Ferguson Research Admin Buzz meeting



Industry Proposal Submissions

[email protected]

Unless the proposal is from GTRI, then it goes through WebWISE.

mailto:[email protected]



SequestrationBudget Control Act of 2011 Automatic, across-the-board spending cuts are scheduled to occur in January 2013Affect both mandatory and discretionary spendingSplit evenly between defense and nondefense accounts



NSF PAPPG 13-1Release Date: October 2012Effective Date: January 2013Features-– Clarification and enhancement of review

criteriaBroader ImpactsIntellectual Merit



NSF PAPPG 13-1Updates to guidance for indirect costsNew format for submission of Facilities, Equipment, and Other Resources in Fastlane– Assist compliance w/ NSF cost sharing policy

Info on Award Cash Management $ervice (ACM$) that will replace Fastlane Cash Request Service



NSF PAPPG 13-1Modification to COI coverage, Office of General Counsel to work w/ institutions that report an unmanageable COI

New guidance on Dual Use Research or Concern



Travel RegulationsThe recently released Travel & Expense (Aug 2012) updates and enhancements:To clarify page 5 info on Business Class Travel:The below statement applies to all of campus if traveling on federal sponsored travel.GTRI is required to adhere to Federal Travel Regulations which prohibit Business class airfares for trips less than 14 hrs. Please consult your unit Business Officer to determine if your project or funds source will allow business class travel.https://techworks.psauth.gatech.edu/gt_data/content/201208_travelexp_updates_and_enhancements-alt.pdf

https://techworks.psauth.gatech.edu/gt_data/content/201208_travelexp_updates_and_enhancements-alt.pdf

https://techworks.psauth.gatech.edu/gt_data/content/201208_travelexp_updates_and_enhancements-alt.pdf



WebWISEReporting Tools–webwise.gtri.gatech.edu

COGNOS Awards Report

New way to submit RCR Deliverable



RCR FAQsWhat is an RCR deliverable and how do I satisfy it?Answer: The RCR deliverable is an annual certification from the PD/PI asserting that the RCR training requirements for the award have been met.Copy/paste the following statement in the “comments to OSP” in the Deliverable system. The PI must also check the box “cannot upload file.” Hit submit.The statement is:I certify that all of the students (undergraduate, graduate) and postdoctoral fellows funded by this project have complied with the Georgia Institute of Technology Responsible Conduct of Research Policy. I understand the following documentation system will be the system of record for Phase II: In Person Training.



RCR FAQsAre postdocs allowed to attend PHIL 6000?

Answer: Yes but the process of registering is different for postdocs than it is for graduate students. Postdocs must receive a registration link from OSP for the course. [Since they aren’t matriculated students they cannot register for the course and the record won’t be in Banner.]



RCR FAQsWhat options do postdoctoral researchers have to complete the in-person RCR training requirement?

Answer: Postdoctoral researchers can:a. Participate in a class, seminar, or other interactive approach developed by the School that addresses ethical issues relevant to the discipline as well as broader issues of research integrity; orb. Participate in regularly scheduled laboratory meetings or discussions that address ethical issues relevant to the discipline as well as broader issues of research integrity; orc. Register through OSP’s system and attend the Research Ethics Course (PHIL 6000) offered by the Ivan Allen College; or



RCR FAQsMany departments have methods courses that cover RCR topical areas. The PI and post-doc can write up a plan of action as to what days to attend the class to appropriately cover the required 4 hours of training. This plan should be agreed to by both parties and kept in the departmental project file. This kind of decision would be left up to the departments if they want to do this and also have the space in these classes.



CRA Study GroupNew Certified Research Administrators– Jim Childers– Sandy Barber– Gabrielle Slappey– Candice Ferguson

Next CRA Study Group will start Thursday, September 20 (lunch will be provided) www.cra-cert.org

http://www.cra-cert.org/



THANK YOU FOR COMINGResearch Admin Buzz

office of research integrity assurance

Documents

healthcare research

new funds

department of health

new awardstype

public health service

toany phs research funding

proposal submission

noncompeting continuationstype